2026 ASEE Annual Conference & Exposition

A vast amount of technologies require approval through a regulating body prior to market entry. The Food and Drug Administration (FDA), for example, regulates medical devices while the National Highway Traffic Safety Administration (NHTSA) aids in regulating the automotive industry. These bodies rely heavily on consensus standards from organizations (e.g., ISO, ASTM, IEC) that consolidate best practices regarding safety and effectiveness. Consensus standards are mutually agreed-upon performance expectations established by expert stakeholders for a given technology or testing method. These standards are generally voluntary and represent best practices derived from experience and data. For example, when an engineer purchases a Grade 5 ¼”-20 hex-head bolt, they know it fits tolerances defined by ANSI/ASME B1.1. Because of this predictability and reproducibility, engineers across the design cycle use consensus standards widely. However, engineering education often superficially covers the use of consensus standards—if addressing them at all—resulting in graduates learning these skills on the job.
Here, we provide a multipronged approach to improve student competencies in modules that evoke a deep understanding of when, how, and why consensus standards are used in the design cycle. While founded in the regulation-intense field of medical device development, our four modules are designed to teach engineers across disciplines and learning levels how to 1) source appropriate standards, 2) write and execute protocols from standards, 3) revise consensus standards, and 4) create new consensus standards.
In collaboration with the engineering librarian, to support standards information literacy, our first module consists of a standards research guide to aid educators and students with resources to identify and source appropriate consensus standards. Resources include free-to-use websites such as the FDA’s Standards Database and organization-based tools like ASTM-Compass. Our second module incorporates consensus standards into both the pre-concept phase (via design requirements) and the verification phase (via standards-based protocol development and execution). This module is integrated across a majority of our BME Senior Design 2-semester course sequence. The third module uses a custom-built benchtop tensile testing apparatus for round-robin testing during an in-class activity. Over multiple sessions, teams characterize tensile properties of a given material and use the round-robin methodology to identify limitations and propose revisions. Notably, materials, device, and protocols include deliberate adulterations to facilitate discrepancies for student teams to identify. Lastly, and the primary focus of this SHARE paper, our fourth module reaches Bloom’s highest levels of learning, challenging students to create new standards and consider ethical challenges in consensus standard development. Students participate in a role-playing activity modeled after murder mystery parties, each given a fake name, background, and role within a company invited to a standards committee focused on pogo stick safety and efficacy. With each company having underlying goals and each individual their own biases, the class must find common ground to draft a consensus standard that appeases key stakeholders.
This paper outlines the curricular content of these modules, provides access to course materials, and discusses findings from incorporation into two design-based biomedical engineering (BME) courses. With these materials, we aim to better prepare students for the engineering workforce.